MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS CORP. QUANTUM EDGE 2.0; WHEELCHAIR, POWERED

Model Number EDGE 2.0

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/22/2017

Event Type  Injury  

Event Description

My power wheelchair was replaced by another one, but this new wheelchair has "caster jerk" so bad that it is impossible in small spaces.

• Brand Name: QUANTUM EDGE 2.0
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS CORP.
• MDR Report Key: 6756657
• MDR Text Key: 81589380
• Report Number: MW5071316
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EDGE 2.0
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 75